Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Code List
Workbook number
Date of non-serious adverse event
Item
Date of non-serious adverse event
date
C1518404 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Case number
Item
Case number
integer
C1698493 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Non-serious adverse event leading to non-administration of vaccine, visit/contact not done
Item
Has any non-serious adverse event leading to a non-administration of the vaccine or a visit/contact not done or a withdrawn?
boolean
C1518404 (UMLS CUI [1])
C1533734 (UMLS CUI [2,1])
C0392360 (UMLS CUI [2,2])
C1272696 (UMLS CUI [2,3])
C0042210 (UMLS CUI [2,4])
C0545082 (UMLS CUI [3,1])
C1272696 (UMLS CUI [3,2])
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description of AE
Item
Description of AE
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Administration sites
integer
C2368628 (UMLS CUI [1])
Code List
Administration sites
CL Item
10Pn-PD-DiT vaccine / HBV Vaccine (1)
CL Item
10Pn-PD-DiT vaccine / HAV Vaccine (2)
CL Item
DTPa-IPV/Hib vaccine / Infanrix Hexa (3)
CL Item
Non-administration (4)
Item
AE Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Date Started
Item
Date Started
date
C0808070 (UMLS CUI [1])
Date started: post-vaccination periode
Item
Date started: during immediate post-vaccination period (30 minutes)
boolean
C0808070 (UMLS CUI [1,1])
C0231291 (UMLS CUI [1,2])
Date Stopped
Item
date
C0806020 (UMLS CUI [1])
Item
Maximum Intensity
integer
C0518690 (UMLS CUI [1])
Code List
Maximum Intensity
Relationship to investigational products
Item
Relationship to investigational products: Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
C1518404 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
Item
Outcome of AE
integer
C1518404 (UMLS CUI [1,1])
C1624730 (UMLS CUI [1,2])
CL Item
Recovered / resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
Item
Type of medically attended visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Code List
Type of medically attended visit
CL Item
Hospitalisation (HO)
CL Item
Emergency Room (ER)
CL Item
Medical Personnel (MD)